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WARNING:AVOID USE IN PREGNANCY

When pregnancy is detected, discontinue Tekturna HCTas soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus.[See Warnings and Precautions (5.1)]

TEKTURNA HCT SUMMARY

Tekturna†HCT is a fixed combination of aliskiren, an orally active, nonpeptide, potent direct renin inhibitor, and hydrochlorothiazide, a thiazide diuretic.

Tekturna†HCT is indicated for the treatment of hypertension.

Both aliskiren and hydrochlorothiazide are associated with dose-dependent and dose-independent adverse effects. Patients treated with Tekturna†HCT may experience any or all of these adverse effects. For dose-dependent adverse effects, using a strength of Tekturna†HCT with a lower dose of the component suspected of causing the adverse effect may produce better tolerability.

Add-On Therapy

A patient whose blood pressure is not adequately controlled with aliskiren alone or hydrochlorothiazide alone may be switched to combination therapy with Tekturna†HCT.

A patient whose blood pressure is controlled with hydrochlorothiazide alone but who experiences hypokalemia may be switched to combination therapy with Tekturna†HCT.

A patient who experiences dose-limiting adverse reactions on either component alone may be switched to Tekturna†HCT†containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions.

Aliskiren as add-on therapy in the treatment of hypertensive diabetic patients inadequately controlled with valsartan/HCT combination: a placebo-controlled study. [2011.10.01]BACKGROUND: Hypertension frequently coexists with diabetes mellitus, resulting in increased cardiovascular risk. Thus, BP control is crucial in decreasing morbidity and mortality in this difficult-to-treat patient population. OBJECTIVE: The objective of this study was to evaluate the efficacy and safety of aliskiren in hypertensive patients with diabetes not adequately responsive to the combination of valsartan and hydrochlorothiazide (HCT)... CONCLUSION: The reductions in BP with aliskiren added to valsartan/HCT in this study were numerically greater compared with placebo added to valsartan/HCT, although not statistically significant. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT00219102.

Antihypertensive efficacy and tolerability of aliskiren/hydrochlorothiazide (HCT) single-pill combinations in patients who are non-responsive to HCT 25 mg alone. [2009.04]OBJECTIVE: Thiazide diuretics such as hydrochlorothiazide (HCT) are a widely used first-line treatment for hypertension, but most patients will not achieve blood pressure (BP) control with HCT alone and so will require combination therapy. In this study the efficacy, safety and tolerability of a single-pill combination (SPC) of the direct renin inhibitor aliskiren with HCT were investigated in patients non-responsive to HCT 25 mg therapy... CONCLUSION: Aliskiren/HCT SPCs provide clinically significant BP reductions and improved BP control rates in patients who are non-responsive to HCT 25 mg monotherapy. Limitations of the study were the mainly Caucasian patient population and the non-responder design.

The Effect of Tekturna on Endothelial Function and Endothelial Progenitor Cells in Patients With Early Atherosclerosis [Recruiting]
We will study the hypothesis that long-term Tekturna treatment will improve endothelial
function and the production and function of endothelial progenitor cells (EPCs) in patients
with early atherosclerosis. Specifically, long-term Tekturna treatment will increase the
Reactive Hyperemia Peripheral Arterial Tonometry indexes and increase the numbers and the
function of circulating endothelial progenitor cells, compared to placebo, in association
with a reduction in inflammation and oxidative stress.

Aldosterone Breakthrough During Diovan, Tekturna, and Combination Therapy in Patients With Proteinuric Kidney Disease [Recruiting]
Primary Hypothesis: Aldosterone breakthrough will occur at a far lower frequency during
renin inhibition (0-10% over 9 months), alone or in combination with an ARB, compared to
conventional ARB therapy (35-45% over 9 months). The investigators hypothesize that
aldosterone breakthrough occurs due to accumulation of active precursor substances, most
notably angiotensin II, produced in response to conventional RAAS blockade with
ACEinhibitors and ARBs. The investigators believe that direct renin inhibition (DRI) should
minimize this accumulation and therefore significantly lower or possibly eliminate the
breakthrough effect.

Interruption of the renin-angiotensin-aldosterone system (RAAS) with angiotensin-converting
enzyme inhibitors (ACE-Is) and angiotensin receptor blockers (ARBs), alone and in
combination, has become a leading therapy to slow the progression of chronic heart and
kidney disease. Both types of drugs inhibit the formation of aldosterone, a hormone, which
has been shown to have harmful effects on patients with chronic heart and kidney disorders.
This treatment is effective but not perfect since, even after an initial improvement, many
patients become worse over the long term. This may be due to an unexpected increase in
aldosterone, a phenomenon called "aldosterone breakthrough."

The purpose of this study is to find out whether the use of a direct renin inhibitor (DRI)
alone, or in combination with an angiotensin receptor blocker (ARB), will lessen the
occurrence of aldosterone breakthrough since direct renin inhibitors inhibit the formation
of aldosterone at a very early step. This study will compare the effectiveness of adding
Diovan (valsartan) or Tekturna (aliskiren) or a combination of Diovan and Tekturna to the
usual antihypertensive treatment. The investigators will follow blood pressure, aldosterone
levels, and urinary protein levels over 9 months to evaluate which of these therapies is
most effective for treating hypertension in patients with proteinuric kidney disease.

To investigate blood vessels, different techniques will be used. For large arteries, these
will be studied by non invasive methods using detection of the pulse wave or using
ultrasound over the skin of the neck, the wrist and the groin. To study small vessels, the
investigators will perform a biopsy on the buttock, under local anesthesia, and obtain a
small sample of tissue from under the skin, from which the vessels will be dissected. The
investigators have performed many hundreds of these small biopsies over the past 20 years
for similar studies without any complications. The biopsies are very well tolerated. From
this research the investigators will thus be able to learn what the structure and function
of these vessels is in these patients, in comparison to a normal healthy group.

The hypertensive diabetic subjects will then be assigned by chance (randomized trial) to
treatment with the renin inhibitor aliskiren or a comparator, the diuretic
hydrochlorothiazide. Aliskiren is a relatively new drug used to treat hypertension that is
very well tolerated and is now being evaluated in numerous trials in hypertensive diabetic
individuals. The diuretic is a well-know agent used to treat high blood pressure now for
many years, and which is very well tolerated. Physicians, nurses and scientists involved in
the study will be unaware of who is receiving which drug, as will be the patients (this is
the meaning of double-blind trial). However, if there is any problem, the secret code will
be broken and the individual withdrawn from the study. Subjects will be treated for a year,
and the study procedures (non invasive and the biopsy) repeated at 6 months and after one
year of treatment. During the study, blood samples will be drawn and urine collected at
certain intervals to ensure safety of the treatment.

Once tissues are obtained they will be studied in the laboratory. The study of the vessels
will allow treatment us to determine how the treatment with the renin inhibitor aliskiren
affects the structure and function as well as cellular and molecular aspects of arteries of
hypertensive diabetic persons. The investigators expect these studies to provide us
knowledge on mechanisms and perhaps new targets for future therapies of cardiovascular
disease and hypertension.

Further this study will also assess the efficacy and safety of a single pill combination of
Aliskiren, Amlodipine and Hydrochlorothiazide (HCTZ) in patients with moderate hypertension
not adequately responding to a single pill combination of Aliskiren and Amlodipine.